This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract (including the cervix and the lining of the uterus) of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so understanding more about them will help to better understand how to prevent the spread of HIV.

Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: an oral contraceptive pill (COC), Depo-Provera (DMPA), the levonorgestrel IUD (Mirena®), the copper IUD (ParaGard®), or the etonogestrel subdermal implant (Nexplanon®).Immune cells will also be studied from the reproductive tract of women who are not using birth control and who are not at risk of pregnancy for comparison.

Quantification and characterization of immune cell populations and HIV-tropic receptor expression [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

To quantify and characterize immune cell populations and HIV-tropic receptor expression in the upper and lower genital tract and blood at baseline and after 3 and 6 months of typical contraceptive use

Secondary Outcome Measures:

Assessing changes in the vaginal microflora within the first 6 months of contraceptive use [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

To describe the microflora of the upper and lower genital tracts of healthy asymptomatic women before and after 3 and 6 months of typical contraceptive use and to assess changes in the vaginal ecology within the first 6 months of contraceptive use.

Low risk of pregnancy due to sterilization, heterosexual abstinence, or consistent condom use

Eligibility

Ages Eligible for Study:

18 Years to 34 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Healthy women, age 18-34 years, who are HIV negative and non-pregnant.

Criteria

Inclusion Criteria:

Age 18 through 34 years (inclusive) at screening

Non-pregnant women in general good health as determined by the site clinician

Premenopausal with history of regular menstrual cycles (regular cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days)

Women enrolling into the control group only: Regular and consistent condom use, prior surgical sterilization by participant or sexual partner, or heterosexually abstinent for entire study participation

Able and willing to provide written informed consent to be screened for and to take part in the study. Including willingness to undergo all study-related assessments and follow all study-related procedures

Able and willing to provide adequate locator information

HIV-uninfected based on testing performed by study staff at screening (per HIV testing algorithm in Appendices I)

At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial

Exclusion Criteria:

Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment

Use of DMPA within 10 months of enrollment

Pregnancy or breastfeeding within 60 days of enrollment

Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and endometrium)

Any history of immunosuppression (includes diabetes, HIV infection, and chronic steroid use)

Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment

Menses or other vaginal bleeding at the time of Enrollment* (*Women who have vaginal bleeding at the scheduled Enrollment Visit may return at a different date to be re-examined and possibly enrolled provided they are still within the 90-day screening window and meet all criteria).

Vaginal or anal intercourse within 36 hours prior to enrollment

Heterosexual intercourse since last menses that places the participant at risk of pregnancy (without condom use or sterilization of at least one partner)

History of hysterectomy

History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)

Contraindication, allergy or intolerance to use of the contraceptive desired by the participant

Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873170